Day One Biopharmaceuticals - Q3 2024

Executive Summary

• OJEMDA net product revenue reached $20.1M, up 145% quarter over quarter, with total Q3 revenue of $93.8M driven by a one-time $73.7M ex‑U.S. license revenue from the Ipsen partnership.
• Quarterly prescriptions (TRx) surged to 619 (+159% q/q), and payer approval rates remained ~80%, underpinning strong commercial traction in the first full quarter post launch.
• Net income was $37.0M ($0.38 diluted EPS) versus a net loss of $(46.2)M a year ago; the positive swing reflects the Ipsen license revenue and investment income; cost of sales expected to rise to 9%–12% of net product revenue in early 2025 as post‑approval inventory begins to be expensed.
• Management highlighted updated FIREFLY‑1 efficacy durability (Arm 1 median duration of response 18 months) and reiterated catalysts: FIREFLY‑2 (frontline pLGG) enrollment and DAY301 first‑patient dosing targeted for Q4 2024/Q1 2025.
• Stock reaction catalysts: strong sequential demand, durable efficacy update, clarity on cost of sales trajectory, and near‑term DAY301 clinical start; however, absence of Street comparisons limits beat/miss assessment this quarter (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

• Strong commercial adoption: “Our OJEMDA net product revenue for Q3 was $20.1 million, more than double what we reported last quarter” and momentum from new prescribers and high continuation rates.
• Durable efficacy narrative: FIREFLY‑1 Arm 1 median duration of response updated to 18 months, reinforcing treatment durability in real‑world usage per management.
• Balance sheet strength and external validation: $558.4M cash, cash equivalents and short‑term investments post Ipsen licensing and equity financing, supporting pipeline and launch investments.

What Went Wrong

• Reported revenue composition is non‑recurring heavy: Total revenue of $93.8M includes $73.7M license revenue, which is not reflective of ongoing product sales run‑rate—investors should focus on the $20.1M product revenue trend.
• OpEx intensity remains elevated with SG&A at $29.0M (launch spending) and R&D at $33.6M (clinical activity), compressing operating leverage absent license contributions.
• Coverage data inconsistencies: management cites commercial published coverage at 62% and Medicaid at 67% (majority covered), while the slide deck references slightly different coverage snapshots (~64% commercial, ~64% Medicaid); reconciliation reflects evolving payer policy publication timing.

Transcript

Operator (participant)

Hello, ladies and gentlemen, and welcome to the Day One Biopharmaceuticals Third Quarter of 2024 Financial and Operating Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. Please be advised that this conference call is being recorded. I would now like to turn the conference call over to Joey Perrone, Senior Vice President of Finance and Investor Relations. Please go ahead, sir.

Joey Perrone (SVP of Finance and Investor Relations)

Thank you. Hello, everyone, and good afternoon. Welcome to Day One's third quarter 2024 financial and operating results conference call. Earlier today, we issued a press release which outlined the topics we plan to discuss today. You can access the press release and the slides to accompany this conference call on the investors and media section of our website at www.dayonebio.com. An audio webcast with the corresponding slides is also available on the website. Before we get started, I'd like to remind everyone that some of the statements that we make on this call and information presented in this slide deck include forward-looking statements as outlined on slide two. Actual events and results could differ materially from those expressed or implied by any forward-looking statements.

We encourage you to review the various risks, uncertainties, and other factors included in our most recent filings with the SEC and any other future filings that we may make with the SEC. These forward-looking statements are based on our current estimates and various assumptions and reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products and product candidates, operating plans, and performance. You are cautioned not to place any undue reliance on these forward-looking statements, and, as required by law, Day One disclaims any obligation to update such statements. Today, I am joined by Dr. Jeremy Bender, Chief Executive Officer; Lauren Merendino, Chief Commercial Officer; Charles York, Chief Operating and Financial Officer; and Dr. Samuel Blackman, Co-founder and Head of R&D. I will now turn the call over to Jeremy.

Jeremy Bender (CEO)

Thank you, Joey, and good afternoon, everyone. I'm pleased to share our third quarter earnings results with you today. I will also provide an update on the three priorities we've emphasized for 2024. First, the successful launch and commercialization of Ojemda. Second, progress advancing our pipeline. And third, the expansion of our portfolio. Day One had a remarkable third quarter. Ojemda net product revenue for Q3 was $20.1 million, more than double what we reported last quarter. Our early commercial experience is laying the groundwork for the company's future growth. We see Ojemda in relapsed/refractory PLGG as a foundational opportunity for Day One. Our commercial execution following approval in April of this year has driven persistent and steady growth of Ojemda sales. We believe that growth reflects the significant unmet need for new treatment options in the relapsed/refractory pediatric low-grade glioma space.

We previously disclosed that the median duration of treatment observed for patients in Arm One of FIREFLY-1 is 23.7 months. As we work towards a more complete analysis of the follow-up data from our registrational FIREFLY-1 trial, the median duration of response for patients in Arm One has now extended from 13.8 months-18 months, which we believe speaks to the value Ojemda is bringing to patients. Given that unmet need, we remain confident in continued future growth in our Ojemda sales and in the opportunity to increase the breadth and depth of our Ojemda prescribers. As we look ahead to 2025, we remain focused on enrollment in FIREFLY-2, our global Phase 3 frontline PLGG trial, and the opportunity it provides to demonstrate the clinical benefit of tovorafenib as a standard of care in the frontline setting.

You may also recall that we established an ex-U.S. partnership for Ojemda with Ipsen earlier this year. We are working closely with our partners there to support successful registration and commercialization of Ojemda in the E.U. and additional territories. We are also on track and on plan to dose the first patients in Q4 this year or early Q1 next year in the Phase 1 trial of DAY301. DAY 301 is the PTK7 targeted ADC we in-licensed mid-year following clearance of the IND by the U.S. FDA for that program. In DAY301, we have an opportunity to establish a first and/or best-in-class program with potential across a broad set of adult and pediatric solid tumors. Finally, as always, we continue to seek opportunities to drive value for our shareholders.

Our business development team continues to actively look for differentiated, high-quality clinical stage programs that fit our portfolio criteria and provide opportunities to improve patients' lives and build value. We are in a strong financial position with over $500 million in cash to fund our operating plan and to expand our portfolio in 2025. We've made great early strides toward delivering on our mission in 2024 to develop new medicines for people of all ages with life-threatening diseases, and we're looking forward to continuing that work ahead. I'll now turn the call over to Lauren to discuss our commercial progress in greater detail.

Lauren Merendino (Chief Commercial Officer)

Thank you, Jeremy, and hello, everyone. Today, we are thrilled to provide an update on our launch of Ojemda with remarkable progress in Q3 on multiple fronts. In the five months since our approval, we have delivered a total of $28.3 million in net revenues driven by over 850 total prescriptions and high payer approval rates. The momentum is encouraging, and we believe there is continued opportunity for the brand. There are many more eligible PLGG patients who can benefit from Ojemda, and we have laid a solid foundation for future growth as we continue to further penetrate this market. This quarter, we delivered $20.1 million in net product revenue for Ojemda, which represents an impressive 145% increase over last quarter. There are two primary factors driving this growth. First, we continue to drive a strong flow of new patient starts.

We are expanding our prescriber base and increasing use by existing prescribers, resulting in a steady influx of new patients. Secondly, we've seen a high percentage of patients continuing on therapy each month. This high continuation rate for PLGG patients is consistent with what we saw in FIREFLY-1, where patients remained on Ojemda for a median duration of about 24 months. In addition to these two demand drivers, Ojemda has continued to see high payer approval rates, so the large majority of our patients are on paid drug with low utilization of our free drug programs. Our volume in Q3 grew by almost 160%, reaching over 600 total prescriptions. This reflects both the growing pool of patients on Ojemda and the high % of patients continuing on therapy.

We've also been able to nearly double our prescriber base in Q3, and about 80% of our Ojemda prescribers have no experience with Ojemda prior to launch. Additionally, we're seeing increased prescriber comfort with Ojemda, with the number of HCPs with two or more patients on our drug continuing to increase. The breadth of patients receiving Ojemda is also notable. Since launch, we've had significant uptake in treating both patients with BRAF fusions and mutations and with patients who have tumors that span the spectrum of locations for PLGG. We believe this broad applicability reinforces the value proposition of Ojemda in the treatment of relapsed/refractory PLGG patients. As we analyze our data, we're seeing early signs of increasing use in second- and third-line therapy.

This is consistent with our expectations that as physicians gain greater confidence with Ojemda, they will move it earlier in their treatment paradigm. Feedback from customers has been overwhelmingly positive regarding Ojemda's product profile, our patient support programs, and the overall ease of access to the medicine. However, we recognize that it'll take time to fully penetrate this market due to the slower progression rate of this disease and the relative infrequency of treatment decisions. Through our efforts, we continue to build momentum for Ojemda, and we see evidence of this in our market research as well as our sales results. In a recent survey of 24 PLGG treaters, 100% of them were aware of Ojemda, and over 90% of them intended to prescribe it. This is up from 64% from a larger survey done around launch.

Additionally, when we look at the top tier of accounts that treat the highest volume of PLGG patients, over 80% have started one or more patients on Ojemda. On the right, we've included a few quotes from our customers highlighting their belief in our product profile and how they are evolving their treatment paradigm to incorporate Ojemda. In addition to making progress with physicians, in Q3, we also made substantial progress establishing published payer coverage. Since early in our launch, we've seen high payer approval rates, which are now about 80% across all payers. This has enabled us to have a high percentage of patients on paid drug. It's also important that we establish published coverage because that will reduce the number of patients who need to navigate an appeals process with their payer.

We made a tremendous amount of progress on this front this quarter, increasing Medicaid coverage by 17% and commercial coverage by 48%. We can now say that the majority of patients have established coverage for Ojemda, with 62% of commercial and 67% of Medicaid patients having established coverage. As we look ahead to Q4, we continue to focus on the fundamentals that will drive our business. We must continue to grow the breadth and depth of our prescriber base, position Ojemda as the standard of care in second-line treatment, and secure payer coverage policies for the remaining patients who do not have coverage today. We're excited about the progress we've been able to make in the first five months of launch, but this is just the beginning.

We continue to see considerable potential in this market, and we are highly motivated by the continued interest and excitement from our customers. Now, for more details on our financials, I'll turn it over to Charles.

Charles York (Chief Operating and Financial Officer)

Hello, everyone. Earlier today, we reported detailed third quarter 2024 financial results in our earnings release. These results highlight our continued focus on value creation. As Lauren mentioned, we have experienced strong patient demand for Ojemda since launch, resulting in Day One recording $20.1 million of Ojemda net product revenue in the third quarter, our first full quarter of revenue. Our Q3 results bring our year-to-date net product revenue to $28.3 million for 2024. Additionally, we closed two transactions: a license of our ex-U.S. commercial rights for tovorafenib and an equity financing, both of which resulted in over $280 million of incremental capital for Day One's future development. As we announced in July, we licensed our ex-U.S. commercial rights for tovorafenib to Ipsen for upfront cash, future milestone and royalty payments, as well as an equity investment made at a market premium.

As a result of that transaction, we recorded $73.7 million of license revenue in the third quarter of 2024. It is important to note that an incremental $4.5 million of license revenue will be recorded over the coming years. In a partnership such as ours with Ipsen, U.S. GAAP requires deferral and subsequent recognition of the allocated transaction price for the future R&D services Day One is contractually obligated to perform. While minor variability is expected, we believe the recognized license revenue will be approximately $300,000-$500,000 per quarter. Cost of sales for the current quarter includes intangible amortization and sales-based royalties. As stated last quarter, we expect cost of sales to increase to 9%-12% of net product revenue early next year as the sale of post-approval cost of inventory commences.

Our total operating expenses were $64.1 million for the current quarter, compared to $51.4 million in the same quarter last year. This increase relative to the third quarter of 2023 was driven primarily by commercial investments that supported the U.S. launch of Ojemda. At Day One, we continue to approach capital allocation in a disciplined manner. We have a clear and focused operating plan, and when paired with our strong cash position of $558.4 million, we are well-funded for measured investment in expanding our pipeline and for continued investment in clinical development across multiple programs. In closing, our achievements during the third quarter of 2024 represented important steps in Day One's path to transformation to a commercially sustainable company, with Ojemda serving as the foundation of value and growth.

These events included enrollment in our frontline PLGG trial for Ojemda, DAY301, our PTK7 targeted ADC is nearing a clinic in the U.S., and we took multiple steps to successfully strengthen our balance sheet. We will finish the year strong with continued urgency and continued focus on delivering new medicines. Now, we will turn it over to the operator for Q&A.

Operator (participant)

Thank you. For the Q&A section of the call, we ask that all participants limit their question to one with an opportunity to have one follow-up question. We will now open the line for questions. If you would like to ask a question, please press star and then one now. A confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove yourself from the question queue. Again, if you would like to ask a question, please press star and then one now. The first question that we have comes from Anupam Rama of JPMorgan. Please go ahead.

Anupam Rama (Analyst)

Hey, guys. Thanks so much for taking the question and congrats on the quarter. Just a quick logistical question. I think you noted around $2 million of inventory in 2Q. Maybe you can comment on what you're seeing in terms of inventory levels in 3Q and how we should think about that going forward. Thanks so much.

Jeremy Bender (CEO)

Thanks, Anupam. This is Jeremy. Appreciate you joining and the question. Let me ask Charles to comment on the inventory topic.

Charles York (Chief Operating and Financial Officer)

Super. So Anupam, from our perspective, as we look forward, it was, or as we look back, rather, it was important for us to provide the level of channel stock in the first quarter of revenue for us, so in Q2 of 2024, given the fact that there is stocking inventory as commensurate with our distribution model. In that quarter and going forward, what we will discuss is that similar guidance that we've provided, which is approximately two to four weeks of channel stock on hand. And when we look at that, that really translates into continued inventory and continued channel stock at the specialty pharmacies, but something that is not contributing materially to our overall revenue. We will not provide the individual number any further. We'll just provide some guidance if we're off that two to four week of channel stock on hand.

Anupam Rama (Analyst)

Thanks so much for taking our question.

Operator (participant)

Thank you. The next question we have comes from Joe Catanzaro of Piper Sandler. Please go ahead.

Joseph Catanzaro (Analyst)

Hey, everybody. Appreciate you taking my question and congrats on the ninth quarter here. Just wondering maybe if you could sort of elaborate a little bit more on the cadence of new patient starts, whether what you saw in 3Q was sort of in line with what you observed in May or June, whether there are maybe still sort of early launch factors at play here, or you believe what you saw in 3Q will continue for the foreseeable future moving forward? Thanks.

Jeremy Bender (CEO)

Thanks, Joe, for the question. Let me comment, and I'll ask Lauren to add any detail. What we saw in the third quarter is very consistent with what we did in the second quarter, and that is continued and consistent adds in terms of new patients. And that is the pattern that we expect going forward. We did not see any substantive change in that pattern in the third quarter relative to our launch quarter, which was the second.

Lauren Merendino (Chief Commercial Officer)

Yes. And we continue to hear from physicians that there are patients that they're treating today that have potential to go on Ojemda in the future. So we do believe there continues to be a lot of potential for the product to be used in more patients in the future.

Joseph Catanzaro (Analyst)

Okay. Got it. That's helpful. And then if I could just ask one quick follow-up, I guess, a technical question. So the TRx number that you're mentioning here, is it fair to assume that each TRx is one month of drug supply, or are there scripts being written for a longer-term supply of drug?

Jeremy Bender (CEO)

Yeah. Let me ask Lauren to answer that.

Lauren Merendino (Chief Commercial Officer)

Yes. A TRx is roughly 28 days' supply. The only exception would be for a QuickStart patient getting a second shipment. It's only two weeks, and that would count as a TRx. But we have very few patients leveraging our QuickStart program at this point since we have such high payer approval rates.

Joseph Catanzaro (Analyst)

Okay. Great. That's helpful. Thanks again for taking my question.

Jeremy Bender (CEO)

Thanks, Joe.

Operator (participant)

The next question we have comes from Andrea Newkirk of Goldman Sachs. Please go ahead.

Andrea Newkirk (Analyst)

Hi, everyone. Thanks for taking the question. Lauren, could you just clarify the number of patients that you do have on drug currently? I think as of 2Q, it was 157, and maybe the breakdown there for EAP vs de novo, and then just really quickly, what percentage of patients from that 2Q cohort did continue on treatment in 3Q? Thank you so much.

Lauren Merendino (Chief Commercial Officer)

Yeah. Thank you for the question. So we're not providing specific numbers. What I can say is that we provided the breakdown in Q2 between EAP and new patient starts, so that is the same. There were an additional three EAP patients that we transitioned in Q3, and now EAP transition is completed. So all the other new patient starts are de novo new patient starts in Q3. And the TRx numbers represent the refill prescriptions from patients continuing from Q2, as well as any prescriptions from the patients starting in Q3, both their initial script and any refills. And so TRx will be what we plan to provide moving forward.

Andrea Newkirk (Analyst)

Okay. Thank you. And then just you mentioned the high continuation rate. Are you giving maybe a number to that, if possible?

Lauren Merendino (Chief Commercial Officer)

Yeah. So we've been really pleased with the continuation rate for PLGG patients. So we see the discontinuations five months into launch is in the low single digits.

Jeremy Bender (CEO)

Yeah. Andrea, let me add to that that we're observing in the commercial setting what we very much would expect to, based on the data that have been generated in FIREFLY-1, where you saw persistent treatment and long durations of treatment, at least so far in the launch, and nothing has really diverged from that expected pattern at this stage.

Operator (participant)

Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one now. The next question that we have comes from Soumit Roy of Jones Research. Please go ahead.

Soumit Roy (Analyst)

Congratulations, everyone, on the great, solid quarter. One quick question. If you are seeing or getting any comments from the community setting physicians, what kind of traction you are getting there or any resistance in terms of they want to see a longer duration on drug before getting in?

Jeremy Bender (CEO)

Soumit, thanks for the question. Lauren, if you could answer that one.

Lauren Merendino (Chief Commercial Officer)

Yeah. So we've seen significant uptake both in academic as well as community physicians. And some physicians had experience prior to launch through clinical trials and EAP. But when we look at our total prescriber pool, 80% of them had no experience prior to launch, and a large number of those are in the community setting. So we haven't heard any resistance in the community setting other than, obviously, many of them are managing a smaller population of patients, so they may have less frequent opportunities to make a treatment decision. But other than that, we've seen uptake in both academic and community.

Soumit Roy (Analyst)

Thank you for that, and one quick question on the frontline trial. Are you getting patients? If you can comment, are you getting patients any post-MEK inhibitors after surgery, or you are seeing physicians equally? Is there any enrollment hindrance coming from physicians putting MEK inhibitors post-surgery and before tovorafenib?

Jeremy Bender (CEO)

Chairman, let me hand to Sam for that one.

Samuel Blackman (Co-founder and Head of R&D)

Thanks for the question, Sumit. The frontline trial is for patients who need their first systemic therapy, so it's not possible for patients to get a MEK inhibitor before tovorafenib in the frontline trial. There will be patients who are enrolled after surgery, and then there are going to be patients who are surgically ineligible enrolled as their first treatment.

Operator (participant)

Thank you, sir. The next question we have comes from Alec Stranahan of Bank of America. Please go ahead.

Alec Stranahan (Analyst)

Hey, guys. Thanks for taking my questions. Two from me as well. Maybe first, just a quick follow-up on the cadence of new patient starts in 3Q. Curious whether patient adds were fairly linear during the quarter or maybe some seasonal lumpiness during the summer. Any additional color you could add sort of on the cadence of new patient adds?

Jeremy Bender (CEO)

Alec, thanks for the question. The cadence, what we can say is that the cadence was very consistent. We didn't observe any significant seasonality. So it was really very straightforward. And that's been true for both the second quarter, the post-launch quarter, as well as this first full quarter.

Alec Stranahan (Analyst)

Okay. Thanks, Jeremy. Makes sense. And maybe just a follow-up, given the new duration of response data you've shown from FIREFLY-1, wondering how you're thinking about this 18-month translating to the real world. Maybe anything you can say on types of patients you're treating currently versus the clinical study and any feedback you've been getting from the field would be great. Thanks.

Jeremy Bender (CEO)

First, let me comment on the new data that we did provide. The first is that we've seen duration of treatment data that we disclosed in the second quarter results of just under 24 months. Then the new data point that we disclosed in our release today is a duration of response data set. Let me ask Sam to comment first and then any other team members.

Samuel Blackman (Co-founder and Head of R&D)

Yeah. Thanks, Alec. Just a comment from the clinical side. I think that the updated duration of response data ultimately is going to give confidence to prescribers that the responses that we're seeing are increasingly durable. At the end of the day, the duration of treatment is not necessarily linked to the radiographic response. And I think, as we've discussed multiple times, small changes in the size of the tumor, which may, on a clinical trial, delineate or be indicative of radiographic progression by standardized response assessment criteria, isn't necessarily a trigger for physicians to stop or change treatment. And as we've said multiple times before, pediatric neuro-oncologists treat patients. They don't treat scans.

So at the end of the day, I don't think that this changes the duration of treatment, but what it does do is give, I think, a great deal of confidence that the responses that we're seeing are really remarkably, remarkably durable.

Alec Stranahan (Analyst)

Great. Thank you. And congrats on the progress.

Jeremy Bender (CEO)

Thanks, Alec.

Operator (participant)

The next question we have comes from Ami Fadia of Needham & Company. Please go ahead.

Ami Fadia (Analyst)

Good evening. Thanks for taking my question. It would be helpful if you could give us some color on the number of patients that are on treatment. The way I was sort of doing the math based on the 600 prescriptions, assuming that all of the 157 from last quarter had three scripts each, that gets us to 471, leaving 129 scripts, and if you assume an average of one and a half months, that brings us to about 86 patients added in the quarter. Does that math roughly kind of align with what you guys are seeing?

Jeremy Bender (CEO)

Ami, thanks for the question. As Lauren noted, we're not focused on the disclosure of specific patient numbers quarter by quarter. So I won't comment specifically on the numbers that you arrive at. Our focus really is on driving overall commercial performance. And what I would reiterate is that the pattern that we observed in terms of the addition of new patients in the third quarter was very consistent throughout that quarter and indicates continued demand at a steady pace.

Ami Fadia (Analyst)

Got it. And then maybe just a quick one on DAY301. You're getting ready to start dosing patients or actually just started dosing patients. Can you just give us a high-level sense of what type of data could we expect to see next year? Thank you.

Jeremy Bender (CEO)

I mean, yeah, we are poised to start that trial and dose the first patient relatively soon. I would reiterate our guidance here that that will occur in Q4 or early Q1, and we're very much on track for that start. We have not specifically guided to when we'll have any early data from the phase one portion of that trial. As you can imagine, that will depend on a number of factors. We do think there will be a lot of interest in the trial and that we'll move quickly. That being said, it isn't clear yet whether we'll have any specific data that will be published or available in 2025, so we'll have to come back to that question and provide more detail on when those data may be available in subsequent quarters.

Ami Fadia (Analyst)

Understood. Thank you so much.

Jeremy Bender (CEO)

Thank you, Ami.

Operator (participant)

Ladies and gentlemen, just a final reminder. If you would like to ask a question, please press star and then one now. The next question we have comes from Andres Maldonado of H.C. Wainwright. Please go ahead.

Andres Maldonado (Analyst)

Hi guys. Congrats on the quarter, and thank you for taking my questions. Maybe just two quick ones from me. The first one, looking prospectively at the collaboration with Ipsen, what is the impression they've given you on some of the differences of launching a RAF inhibitor in the U.S. vs the E.U.? And is there an approved RAF inhibitor in both scenarios where we could use as a reference point to set our expectations there? And then my last question on the PTK7. Obviously, competitors have generated intriguing signals across a myriad of tumor types. Curious on what's the thinking towards combination work here and how much preclinical work has been done there guiding your strategy moving forward? Thank you very much.

Jeremy Bender (CEO)

Understood. Thank you for the questions. Let me start with your question about Ipsen. There are, outside of the U.S. and in the U.S., of course, a number of RAF inhibitors that are Type 1 RAF inhibitors that have been approved. Those are really limited to adults with disease driven by predominantly V600E mutations in their tumors. And those have been around for some time. I don't remember the specific initial approval there. But those are distinct from Ojemda's approval here in the U.S. Ojemda tovorafenib is a Type 2 RAF inhibitor and a unique mechanism of action for that reason, albeit against a similar target. In terms of the discussions that we've had with Ipsen, we can't really talk in detail about the nature of those.

What I can tell you is that we have very clear alignment on the registration strategy for Ojemda in markets outside of the U.S. and confidence in Ipsen's ability to achieve those approvals and are well on the way towards supporting their efforts for submission. With respect to your second question about PTK7 and potential combinations, I'm going to make one comment and then hand to Sam for a little nuance. From my perspective, one of the features of that specific program is that we can pursue, through a Phase 1, 1b, and Phase 2 cohort expansion strategy, clear signal-seeking work that will allow us to understand the potential registration paths for that program across a fairly sizable number of tumors because we have the potential for single-agent activity.

That, of course, does not address the longer-term question of whether those registration paths could involve combinations, which, of course, many of them may. For that, let me hand to Sam to talk in more detail.

Samuel Blackman (Co-founder and Head of R&D)

Yeah. Thanks. It's a thoughtful question. Just to build on what Jeremy said, our development plan, and I think I don't want to speak for all of my colleagues in drug development who are working on ADCs, but having worked in this space before, I think all of us share this common belief that a well-designed, well-targeted ADC is going to be active as monotherapy. And our early phase development program is designed to elicit a monotherapy signal of activity. If you look at the history of ADC development, combination work has taken place, and certainly in bladder cancer with enfortumab vedotin in combination with a checkpoint inhibitor, but that was really subsequent to the approval of that as monotherapy. I think for us, the most important thing is for us to be laser-focused on eliciting a monotherapy signal.

As such, we've designed a very efficient Phase 1 clinical trial and look forward to bringing the same type of high-quality execution to it that we brought to our work in low-grade glioma, and we'll do, I think, all due diligence on potential combinations for later stage development should it be necessary, but again, this next year is really about highly efficient execution of our Phase 1 trial.

Andres Maldonado (Analyst)

Great. Thank you very much.

Jeremy Bender (CEO)

Thanks, Andres.

Operator (participant)

Thank you. Ladies and gentlemen, we have reached the end of our conference call. Thank you for joining us. You may now disconnect your line.